Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The use of the term Universal Transport Medium or UTM, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
OBJECTIONS
3. The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
4. Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
ELECTION
5. Applicant’s election without traverse of Group I in the reply filed on 03/03/26 is acknowledged.
6. Claims 40-44 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/03/26.
7. Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
NON-PRIOR ART REJECTION
8. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 26 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Firstly, this claim is indefinite because of the language ‘Hank’s balanced salt solution’ and ‘Viral Transport Medium (VTM)’. Although these terms are known in the prior art, they are not defined in the specification, and the Office has not found any evidence that there is an accepted, standard understanding in the prior art as to exactly what components are required in these reagents. Thus, clarification is required.
Secondly, this claim contains the trademark/trade name ‘Universal Transport Medium (UTM)’. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a type of solution or medium and, accordingly, the identification/description is indefinite.
PRIOR ART REJECTIONS
9. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
10. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 23-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smyrlaki et al. (23 Sept 2020).
Regarding these independent claims, Smyrlaki teaches a method comprising: preparing a crude biological sample for amplification-based detection of a target nucleic acid, and subjecting at least an aliquot of the sample to an amplification reaction and amplifying the target nucleic acid. Regarding claim 2, Smyrlaki further teaches a target nucleic acid derived from a coronavirus. See entire document on pages 1-11 and Supplementary Information, Figs. 1-2 and Tables 1-3. The claimed methods cannot be distinguished from the method taught by Smyrlaki.
11. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 25-39 are rejected under 35 U.S.C. 103 as being unpatentable over Smyrlaki.
The teachings of Smyrlaki are discussed above.
Smyrlaki does not teach the exact extraction composition required in these dependent claims.
However, these claims recite nucleic acid extraction reagents, such as surfactants, buffers, various salt solutions, nuclease inhibitors, and reducing agents, which were unarguably routine and conventional in the prior art of nucleic acid sample preparation for amplification, and it would have merely involved routine optimization of known-important reaction parameters to optimize the extraction composition and procedure of Smyrlaki to achieve the methods of the dependent claims. It is well established in U.S. patent practice that such routine optimization does not support unobviousness (M.P.E.P. 2144.05). It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to carry out the claimed methods.
For the sake of completeness, it is noted that some of the results in the Examples in the specification are characterized as surprising, unexpected, or synergistic. However, the Office has not found any claim which is limited in such a way as to require steps and reagents corresponding to what is described as surprising, unexpected, or synergistic in the specification. Applicant may wish to amend the claims such that there is a nexus with such results, and provide a full explanation as to why they are considered to be surprising, unexpected, or synergistic.
CONCLUSION
12. Vranes et al. (US 2023/0357824) is made of record as a reference of interest.
13. No claims are free of the prior art.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNETH R HORLICK whose telephone number is (571)272-0784. The examiner can normally be reached Mon. - Thurs. 8:30 - 6:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Benzion can be reached at 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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04/29/26
/KENNETH R HORLICK/ Primary Examiner, Art Unit 1681
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